DEN230061 is an FDA 510(k) submission for the allay Nerve Cap. This device is classified as a In Situ Polymerizing Peripheral Nerve Cap (Class II - Special Controls, product code SBG).
Submitted by Tulavi Therapeutics (Lost Gatos, US). The FDA issued a Not Cleared (DENG) decision on July 16, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5260. An In Situ Polymerizing Peripheral Nerve Cap Is A Prescription Use Only Device Composed Of Precursor Materials That Polymerize When Delivered To The End Of A Peripheral Nerve To Function As A Physical Barrier To The Surrounding In Vivo Environment To Reduce The Risk Of Formation Of A Symptomatic Neuroma..
| 510(k) Number | DEN230061 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 12, 2023 |
| Decision Date | July 16, 2024 |
| Days to Decision | 308 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | SBG - In Situ Polymerizing Peripheral Nerve Cap |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5260 |
| Definition | An In Situ Polymerizing Peripheral Nerve Cap Is A Prescription Use Only Device Composed Of Precursor Materials That Polymerize When Delivered To The End Of A Peripheral Nerve To Function As A Physical Barrier To The Surrounding In Vivo Environment To Reduce The Risk Of Formation Of A Symptomatic Neuroma. |